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Diabetic Kidney Disease (DKD)Phase 1/2NCT06866158

Autologous Dendritic Cell as Adjunct Therapy for Diabetic Kidney Disease

A Phase 1/2 study testing Dendritic cell immunotherapy in people with Diabetic Kidney Disease (DKD), run by PT. JES Kasih Nusantara Sejahterah at 1 site in Indonesia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this single-arm, open-label clinical trial is to evaluate the effects of subcutaneous autologous dendritic cell (DC) and lymphocyte administration on albuminuria and endothelial dysfunction in Type 2 Diabetes Mellitus (T2DM) patients with Diabetic Kidney Disease (DKD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Kidney Disease (DKD)
What is being tested?
Dendritic cell immunotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteIndonesia
Study dates
1 May 2024to 5 Aug 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female over 18 years old
  • Understands and agrees to comply with study procedures by providing written informed consent.
  • In the investigator's judgment, the subject is able and willing to comply with study procedures.
  • In the investigator's judgment, the subject is in generally good physical and mental health. This includes the following factors:
  • Age > 65 years
  • Mild to moderate obesity (BMI 30 to 40)
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  • Controlled hypertension with medication
  • Controlled hyperlipidemia with medication
  • Mild chronic lung disease
  • Previously diagnosed with cancer and in remission for at least 1 year
  • Meets the diagnostic criteria for Type 2 Diabetes Mellitus (DM) according to Indonesia's Endocrinology Society (PERKENI) 2021.
  • eGFR ≥ 30 mL/min/1.73 m².
  • Urinary albumin-creatinine ratio (UACR) ≥ 30 mg/g.

Who cannot join

  • Receiving immunosuppressive treatments such as corticosteroids, hydroxychloroquine, methotrexate, cyclophosphamide, and others within the last 4 weeks.
  • Known to have other kidney diseases (e.g., polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis, etc.).
  • Known to have other conditions that can cause albuminuria (e.g., myeloma, rhabdomyolysis, paroxysmal nocturnal hemoglobinuria, orthostatic albuminuria, etc.).
  • Diagnosed with other types of diabetes (Type 1 DM, gestational DM, or other forms of DM).
  • Positive pregnancy test.
  • Known to have immunodeficiency diseases such as human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV); no blood testing required.
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  • Requires oxygen supplementation.
  • Diagnosed with invasive cancer and currently receiving anti-cancer therapy, except for hormonal therapy for breast or prostate cancer.
  • History of thromboembolism or a genetic predisposition to thromboembolism, or currently on anti-thromboembolic therapy other than low-dose aspirin.
  • Physical or mental disabilities preventing normal daily activities.
  • In the investigator's judgment, any illness or medical condition that may hinder the subject's participation, including acute, subacute, intermittent, or chronic diseases that could place the subject at risk of injury, prevent compliance with the study protocol, or interfere with study assessments.
  • Measurable parameters include:
  • Severe obesity: BMI > 40
  • Uncontrolled hypertension: systolic >180 mmHg, diastolic >100 mmHg
  • Unwilling to sign the written informed consent.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Gatot Soebroto Central Army Hospital

    Jakarta Pusat, DKI Jakarta - Jakarta, 10410

Other trials in Indonesia

About this study

Official title: Single-arm Open-label Clinical Trial: Autologous Dendritic Cells and Lymphocytes in Type 2 Diabetes Mellitus With Albuminuria

The goal of this single-arm, open-label clinical trial is to evaluate the effects of subcutaneous autologous dendritic cell (DC) and lymphocyte administration on albuminuria and endothelial dysfunction in Type 2 Diabetes Mellitus (T2DM) patients with Diabetic Kidney Disease (DKD). The main questions it aims to answer are:

  • Does autologous DC immunotherapy reduce urine albumin-creatinine ratio (UACR) in DKD patients?
  • What are the underlying mechanisms (modulation of inflammation, endothelial dysfunction, angiogenesis, fibrosis, and structural changes) through which DC immunotherapy reduces UACR in DKD patients?
Read more

Participants will:

  • Undergo collection of autologous dendritic cells, which will be matured ex vivo using SARS-CoV-2 S protein.
  • Receive a single subcutaneous injection consisting of matured dendritic cells and lymphocyte reinfusion.
  • Have UACR measured at baseline and at weeks 1, 2, 3, and 4 post-immunotherapy.
  • Undergo assessments of other laboratory parameters and kidney imaging (ultrasonography and/or magnetic resonance imaging) at baseline and week 4 post-treatment.
  • What is the effect of autologous DC immunotherapy on knee OA, assessed by radiographic changes (x-ray) and patient-reported outcomes (WOMAC score)?

Additionally, a subgroup of subjects who had neuropathy as comorbidity will be assessed using Electromyography (EMG) and the Toronto Clinical Neuropathy Scale (TCNS). These assessments aimed to determine the impact of the intervention on peripheral nerve function, clinical neuropathy symptoms over the study period. Another subgroup of subjects who had knee osteoarthritis will be assessed their knee x-ray and Western Ontario and McMaster Universities osteoarthritis index (WOMAC) score. These assessments aimed to determine the impact of the intervention on knee anatomic structure, function, and pain.

Being tested
Dendritic cell immunotherapy
Keywords
Dendritic Cell, Immunotherapy, Diabetic Kidney Disease, Cellular Therapy, Autologous
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dendritic cell immunotherapyBiological

    Also called Immunotherapy Nusantara

    DCL (Dendritic Cells+Lymphocytes) previously matured with S-Protein of SARS-CoV-2. The number of cells given depends on individual yields.

Study groups in NCT06866158
Study groupRoleWhat they receive
Autologous DCLExperimentalNot described
Receives: Biological: Dendritic cell immunotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Urine Albumin-Creatinine Ratio (UACR) from Baseline

    UACR were evaluated at a total 5 time points: baseline, week 1, 2, 3, and 4.

    Measured: From baseline to 4 weeks after treament

Secondary outcomes (13)

  1. Change in Estimated Glomerular Filtration Rate

    Estimated glomerular filtration rate (eGFR) calculated from serum creatinine using the CKD-EPI equation.

    Measured: From baseline to 4 weeks after treament

  2. Change in Angiogenesis Biomarker

    An angiogenesis biomarker, vascular endothelial growth factor (VEGF) were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in pg/mL.

    Measured: From baseline to 4 weeks after treament

  3. Change in Interleukin-6

    Interleukin-6 (IL-6), an inflammatory biomarker, was evaluated at both baseline and 4 weeks post-treatment. With measurements expressed in pg/mL.

    Measured: From baseline to 4 weeks after treament

  4. Change in tumor necrosis factor-α

    Tumor necrosis factor-α (TNF-α), an inflammatory biomarker, was evaluated at both baseline and 4 weeks post-treatment. With measurements expressed in pg/mL.

    Measured: From baseline to 4 weeks after treament

  5. Change in interleukin-10

    Interleukin-10 (IL-10), an inflammatory biomarker, was evaluated at both baseline and 4 weeks post-treatment. With measurements expressed in pg/mL.

    Measured: From baseline to 4 weeks after treament

  6. Change in transforming growth factor-β

    Transforming growth factor-β (TGF-β), an endothelial biomarkers, were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in pg/mL.

    Measured: From baseline to 4 weeks after treament

  7. Change in matrix metalloproteinase-9

    Change in matrix metalloproteinase-9 (MMP-9), an endothelial biomarkers, were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in ng/mL.

    Measured: From baseline to 4 weeks after treament

  8. Change in endhotelin

    Endhotelin, an endothelial biomarkers, were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in pg/mL.

    Measured: From baseline to 4 weeks after treament

  9. Change in intercellular adhesion molecule

    Change in intercellular adhesion molecule (ICAM), an endothelial biomarkers, were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in ng/mL.

    Measured: From baseline to 4 weeks after treament

  10. Change in vascular cell adhesion protein

    Change in vascular cell adhesion protein (VCAM), an endothelial biomarkers, were evaluated at baseline and 4 weeks post-treatment. With measurements expressed in ng/mL.

    Measured: From baseline to 4 weeks after treament

  11. Change in kidney perfusion

    Doppler Ultrasonography (Doppler USG) of the kidneys were performed at baseline and 4 weeks post-treatment.

    Measured: From baseline to 4 weeks after treament

  12. Change in kidney tissue and function

    Magnetic Resonance Imaging Diffusion Weighted Imaging (MRI DWI) of the kidneys were performed at baseline and 4 weeks post-treatment.

    Measured: From baseline to 4 weeks after treament

  13. Change in kidney tissue and function

    Magnetic Resonance Imaging Diffusion Tensor Imaging (MRI DTI) of the kidneys were performed at baseline and 4 weeks post-treatment.

    Measured: From baseline to 4 weeks after treament

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2025
  2. Study start1 May 2024
  3. Primary completion5 Aug 2024
  4. Study completion5 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All subjects that fulfilled the enrollment criteria were given a single dose of autologous DC therapy
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06866158
Sponsor's protocol ID
CL-DKD-P01-ID
Status last verified
Nov 2025
First submitted
22 Feb 2025
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only individual participant data (IPD) underlying the results presented in the publication will be shared.

Publications

  • Jonny J, Sitepu EC, Lister INE, Chiuman L, Putranto TA. The Potential of Anti-Inflammatory DC Immunotherapy in Improving Proteinuria in Type 2 Diabetes Mellitus. Vaccines (Basel). 2024 Aug 27;12(9):972. doi: 10.3390/vaccines12090972.

    PubMed 39340004

  • Setiawan E, Ginting CN, Jonny J, Hernowo BA, Putranto TA. Clinical Trial: Effect of Autologous Dendritic Cell Administration on Improving Neuropathy Symptoms and Inflammatory Biomarkers in Diabetic Neuropathy. Curr Issues Mol Biol. 2024 Dec 20;46(12):14366-14380. doi: 10.3390/cimb46120861.

    PubMed 39727989

  • Dimu PS, Icksan AG, Farhat, Jonny, Hernowo BA, Putranto TA. Clinical Trial of Autologous Dendritic Cell Administration Effect on Water Molecule Diffusion and Anti-Inflammatory Biomarkers in Diabetic Kidney Disease. Curr Issues Mol Biol. 2024 Dec 4;46(12):13767-13779. doi: 10.3390/cimb46120822.

    PubMed 39727950

  • Jonny, Sitepu EC, Hernowo BA, Chiuman L, Lister INE, Putranto TA. Open-Label Clinical Trial on the Impact of Autologous Dendritic Cell Therapy on Albuminuria and Inflammatory Biomarkers (Interleukin-6, Interleukin-10, Tumor Necrosis Factor alpha) in Diabetic Kidney Disease (DKD). Curr Issues Mol Biol. 2024 Dec 2;46(12):13662-13674. doi: 10.3390/cimb46120816.

    PubMed 39727944

  • Yana ML, Sitepu EC, Jonny, Chiuman L, Lister INE, Putranto TA. The Effect of Autologous Dendritic Cell Immunotherapy on Kidney Function and Endothelial Dysfunction of Patients with Diabetic Kidney Disease (DKD): An Open Label Clinical Trial. Curr Issues Mol Biol. 2025 Jan 6;47(1):31. doi: 10.3390/cimb47010031.

    PubMed 39852146

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dendritic cell immunotherapy in people with Diabetic Kidney Disease (DKD), run by PT. JES Kasih Nusantara Sejahterah at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Urine Albumin-Creatinine Ratio (UACR) from Baseline (time frame: From baseline to 4 weeks after treament). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06866158, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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